Kornimate/medical-research-clean huggingface dataset:
a pilot study investigating apixaban and dexamethasone interaction in multiple myeloma

Conditions: Anti-Xa Activity

Summary: this pilot study will investigate the impact of dexamethasone (dex) on anti-xa levels in participants taking apixaban 2.5 mg twice a day by mouth (po bid). investigators propose a prospective, cohort study of 24 participants with multiple myeloma, in whom a lenalidomide-dexamethasone (len-dex)-based myeloma treatment regimen is indicated. eligible participants will initiate thromboprophylaxis with apixaban prior to starting their dex-containing regimen and continue until the end of cycle 3. anti-xa levels, d-dimer and plasma drug concentration will be measured. this pilot study looks to investigate this potential interaction between apixaban and dexamethasone to see if it warrants further investigation in a larger study. the sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in peak anti-xa levels from baseline. secondary outcomes include changes in plasma apixaban levels, d-dimer, and symptomatic venous thromboembolism (vte) and bleeding during a 3-month treatment period.

study has terminated due to poor enrollment.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of multiple myeloma according to criteria of the international myeloma working group * patients in whom a len-dex-based treatment regimen is indicated * adult patients ≥ 19 years of age who are able to freely provide informed consent exclusion criteria: * concomitant antiplatelet or anticoagulant use * calculated creatinine clearance \< 30 ml/min by cockcroft-gault formula * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 times upper limit of normal (uln) * total bilirubin \> 2 x uln * thrombocytopenia \< 50 x 10 gigalitres (gl) * high bleeding risk or spontaneously prolonged prothrombin time or activated partial thromboplastin time \> 1.5 x uln * body weight \ 120 kg * concomitant use of cyp3a4 or p-glycoprotein inducers or inhibitors * use of ginkgo biloba or st. john's wort within 14 days before first dose of study drug * dexamethasone use within last 3 months * women of childbearing potential without proper contraceptive measures, pregnancy or breast feeding * life expectancy less than 3 months * inability to swallow or issues with malabsorption * any other medical, social, logistical, geographical or psychological factors, which in the opinion of the investigator, would prohibit follow-up, compliance and study completion
treatment of the acute myeloblastic leukaemia in patients over 65 years

Conditions: Acute Myeloblastic Leukaemia

Summary: to reproduce or to improve the index of complete responses of protocol lma-91 with a similar protocol, decreasing the dose of idarubicin to try to reduce the deaths in induction

induction treatment :ara-c 100 mg/m 2 /day in continuous perfusion,days 1 - 7. idarubicin 8 mg/m 2 /day, days 1 - 3 in bolus. gm-csf (leucomax) 5 mcg/kg subcutaneous or endovenous from day + 4 after finishing the chemotherapy until the recovery of neutropenia (\> 1.000/mm 3) consolidation treatment the patients who reach a complete response with the first cycle, will receive a second cycle to consolidation. the patients who do not reach a complete response with the first cycle will receive a second cycle. if after two cycles,do not obtain the response, patient should leave the protocol. intensification treatment all the patients who are in complete response after one cycle of induction and one cycle of consolidation, or after two cycles of induction, will receive a treatment of intensification with: ara-c 500 mg/m 2 /12 h in one hour infusion, days 1-4. daunomycin 45 mg/m 2 /day bolu, days 5-7. gm-csf (leucomax): 5 mcg/kg from day to + 4 after finishing the chemotherapy until the recovery of neutropenia (\>1.000/mm 3)

Eligibility criteria:
inclusion criteria: * cytologic diagnosis of acute myeloblastic leukaemia (excluded m3) * over 65 years exclusion criteria: * previous diagnosis of other malignancy hematopoietic disorder or myelodysplastic syndrome * previous treatment with antileucemic chemotherapy * psychiatric disorder * diagnosis of subtype fab m3 * creatinine \> 2.5 mg/dl * bilirubin , alkaline phosphatase or transaminases three times upper the limit

Keywords: acute myeloblastic leukaemia
mechanisms of refractory hypertension (high and low salt diet)

Conditions: Hypertension

Summary: the purpose of the study is to test the hypothesis that persistent fluid retention and high sympathetic output contributes to the development of refractory hypertension (htn). the investigators will determine, in a cross-over assessment of high and low salt diets, if dietary sodium restriction reduces 24-hr ambulatory bp in patients with refractory htn. moreover, the investigators will determine if dietary sodium restriction lessens the severity of obstructive sleep apnea (osa) in patients with refractory htn.

we are proposing a unique phenotype of antihypertensive treatment failure that we refer to as refractory htn. we have come to feel that while resistant (rhtn) represents a broad phenotype with multiple and overlapping etiologies of treatment resistance, there is a unique subset of patients who never achieve bp control in spite of maximal therapy. in a recently published retrospective analysis of our clinic experience, we found that patients with refractory htn comprised about 10% of patients referred to us for rhtn. a large number of intervention studies have verified the benefit of dietary salt restriction to reduce bp. we made such an assessment in a prospective, randomized, cross-over comparison of high- and low salt diets in 12 patients with confirmed rhtn. the average reduction in bp going from high to the low salt diet was 23/10 mmhg in the clinic and 20/10 mmhg during 24-hr ambulatory bp monitoring. these dramatic results demonstrated that patients with rhtn are exquisitely salt-sensitive and highlight the degree of bp reduction that can be accomplished with meaningful salt restriction. however, we are proposing the novel hypothesis that refractory htn is mechanistically unique from rhtn in that it is not secondary to recalcitrant fluid retention. determining an association between dietary salt restriction and severity of obstructive sleep apnea (osa) would potentially help us to find new therapies guided towards achieving better control of bp in patients with refractory htn. we will investigate the effect of dietary salt intake on severity of osa vascular function in patients with refractory htn by doing vascular studies (pulse wave analysis/velocity, calculating thoracic impedance)).

Eligibility criteria:
inclusion criteria: * adult subjects ≥ 19 years of age * refractory hypertension defined as office bp \> 140/90 that is uncontrolled with at least 5 different classes of antihypertensive medications * self-reported adherence \>80% with prescribed antihypertensive medications exclusion criteria: * severe hypertension (office bp \>160/100 mm hg) * history of congestive heart failure (ejection fraction of \<40%) * chronic kidney disease (creatinine clearance \<60 ml/min) * history of cardiovascular disease (stroke, tia, myocardial infarction, or revascularization procedure) * white coat hypertension defined as office bp \>140/90 mm hg and ambulatory daytime bp \<135/85 mm hg * pregnant or nursing women
demographic data and clinical presentation of pediatric uveitis

Conditions: Pediatric Uveitis

Summary: to describe and analyze the demographics, clinical characteristics, etiology, and visual outcomes of pediatric uveitis cases attending the outpatient clinic of ophthalmology department, assiut university hospital.

uveitis is a form of eye inflammation that affects the middle layer of tissue in the eye wall (uvea). it is the third leading cause of blindness worldwide .uveitis is more common in adults; however, children comprise 2.2% to 21.6% of patients in various studies.despite a lower incidence of uveitis in children, the rate of visual loss may be worse than that of adults . the onset of uveitis in children is often insidious and is only discovered during routine screening.the lack of significant symptoms and delayed presentation to an ophthalmologist leads to morbidity and a decrease in visual acuity . the length of time between the diagnosis of uveitis and the referral to a tertiary eye center is strongly correlated with the complications rate and degree of visual impairment. uveitis is classified according to the international uveitis study group criteria based on the anatomical location of the inflammation and is categorized as anterior, intermediate, posterior or panuveitis. it is also described based on clinical onset, duration and course. some uveitis syndromes are unique to children, such as juvenile idiopathic arthritis (jia), kawasaki syndrome, familial juvenile systemic granulomatosis and tubulointerstitial nephritis-uveitis syndrome. other conditions are more prevalent in the pediatric population due to environmental factors such as trematode induced uveitis. due to the lack of epidemiological studies on the demographic and clinical characteristics of pediatric uveitis in upper egypt. this study aims to improve diagnosis, management, and treatment strategies tailored to the population.

Eligibility criteria:
inclusion criteria: * uveitis patients \<18 years old * must be able to participate in the study. exclusion criteria: * age over 18 years. * patients with post pentrating ocular trauma. * patients whose legal guardians are unwilling to participate in the study.
a study to assess the efficacy and safety of hmi-115 in subjects with endometriosis-associated pain

Conditions: Endometriosis

Summary: this study is designed to evaluate the safety and efficacy of hmi-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.

this study aims to evaluate the safety and efficacy of hmi-115 versus a placebo in pre-menopausal women with moderate to severe endometriosis associated pain. part 1 of the study will determine the safety and efficacy of hmi 115 at 3 dose levels. part 2 will detect a higher dose and might be conducted after part 1.

Eligibility criteria:
inclusion criteria: 1. pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent. 2. subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening. 3. subject must have a composite pelvic signs and symptoms score total score of ≥ 6 with a score of at least 2 for dys and at least 2 for nmpp at screening. 4. subject agrees not to participate in another interventional study while participating in the present study. exclusion criteria: 1. subject is pregnant or breastfeeding or is planning a pregnancy during the study period. 2. subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain 3. subject has clinically significant gynecologic condition other than endometriosis 4. subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (nsaids) or any contraindication to their use such as gastrointestinal ulcer or bleeding 5. subject has history of hysterectomy and/or bilateral oophorectomy 6. subjects with past or present pituitary tumor growth 7. subjects has a history of osteoporosis or other metabolic bone disease
comparison of contact-force monitoring irrigated tip catheter and mesh-like irrigated tip catheter in atrial fibrillation ablation: prospective randomized trial (commic trial)

Conditions: Atrial Fibrillation

Summary: mesh-type flexible tip (mft) catheter is developed to generate bigger radiofrequency (rf) lesion, and contract force (cf) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (afca). the investigators compared clinical outcome of afca conducted by mft catheter and cf catheter in prospective randomized manner. the investigators prospectively assigned 230 patients with af in a 1:1 ratio to ablation by mft catheter (flexability™, abbott inc. usa) and cf catheter (tacticath™, abbott inc. usa). the primary end point was af recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.

a. study design 1. prospective randomization (flexability group vs. tacticath group ) 2. target number of subjects: 360 (180 per group) 3. rhythm follow-up : 2012 acc/aha/esc guidelines (holter monitoring at the baseline, 2 month, and thereafter every 6 months; ecg if the patient has any symptom) 4. anticoagulant therapy followed by 2014 acc/aha/esc guidelines 5. all complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate. b. progress and rhythm/ecg follow-up 1. to be performed in accordance with the 2012 acc/aha/hrs guidelines for af management 2. follow-up at 2 weeks, 2 months, and thereafter every 6-month. 3. rhythm control at 2 months, and thereafter every 6-month follow-up with holter 4. if the patient complains of symptoms, ecg will be performed at any time, and rhythm follow-up will be carried out with a holter or event recorder.

Eligibility criteria:
inclusion criteria: * appropriate indiction for af catheter ablation (20\~80 years old) * echocardiographically measured left atrial size \< 55mm * anticoagulation eligible patients exclusion criteria: * af associated with significant cardiac anomaly, structural heart disease affecting hemodynamics * ineligible to ct imaging due to significant renal disease * prior history of af catheter ablation or cardiac surgery * active internal bleeding * anticoagulation ineligible patients * valvular af * life expectancy \< 1year * drug or alcohol addicted patients * other unacceptable patients for clinical trial determined by investigators

Keywords: atrial fibrillation atrial fibrillation ablation prospective randomized trial
effectiveness of matrix rhythm therapy on increased muscle tone, balance and gait parameters in stroke survivors

Conditions: Stroke

Summary: matrix-rhythm-therapy(mrt) has been included in neuro-rehabilitation program for stroke patients to regulate increased muscle tone. there are no controlled studies with large sample size on the efficacy of mrt on spasticity. in this context,to the best of our knowledge, our study is the first study on this subject. the results of the study will develop a new perspective for management of spasticity and will ensure more common use of mrt.further studies are needed on superiority of mri over other treatment methods used in gait and balance rehabilitation of hemiparetic individuals. the aim of this study was to investigate the effectiveness of combining bobath therapy (bt) and mrt on muscle tone,balance and gait parameters in stroke individuals with spastic hemiparesis.


Eligibility criteria:
inclusion criteria: * aged between * to discharge from the hospital, * to have single-sided hemiparesis for the first time, * to have hemiparesis at least four weeks earlier. * to have modified rankin score of ≤3, modified ashworth scale score between 1-5 for the lower extremity. exclusion criteria: * to use a cardiac pacemaker, * to have aphasia, open wound in the area to be treated, * to have circulatory problem, skin lesions, other neurological, psychiatric and/or orthopedic problems other than hemiparesis affecting gait.

Keywords: stroke survivor spasticity matrix rhythm therapy balance gait
investigating the safety and effectiveness of insulin degludec in a real world population with type 1 and 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (tresiba®) in a real world population with type 1 (t1dm) and 2 (t2dm) diabetes mellitus.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * male or female patients at least 18 years of age at time of informed consent * t1dm (diagnosed clinically) prior to inclusion in the study, and/or t2dm, insulin using patients (diagnosed clinically) prior to inclusion in the study * planned initiation with tresiba® exclusion criteria: * known or suspected hypersensitivity to tresiba® or any of the excipients listed in section 6.1 of the smpc (summary of product characteristics) or related products * previous participation in this study (i.e. provision of informed consent) * patients who have previously been treated with tresiba® * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
vesicare for improving oab symptoms in patients undergoing igrt of the prostate

Conditions: Over-Active Bladder

Summary: the purpose of this study is to determine if vesicare (solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

this is a randomized double blind placebo controlled flexible dose 12 week study. following screening, subjects will receive their first dose of study medication following completion of auass questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. subjects will be started on 5 mg of study medication. the auass will be completed at baseline, weeks 4, 8 and 12. a 16 week visit conducted over a phone interview.

Eligibility criteria:
inclusion criteria: 1. institutional review board (irb)/independent ethics committee (iec) approved written informed consent and privacy language as per hipaa authorization for the usa test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable) 2. subject must be an ambulatory male at least 18 years of age. 3. subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy. 4. subject is willing to complete the american urology association symptom score (auass) questionnaire. exclusion criteria: 1. subject has undergone a prostatectomy 2. subject exhibits symptoms of urinary tract infection. 3. subject exhibits severe neurologic damage or has undergone prostatectomy. 4. subject diagnosed with oab and is being treated with medication for alleviation of oab symptoms within 12 months prior to the screening visit. 5. subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent uti. 6. subject exhibits hypersensitivity to solifenacin succinate, any ingredients, or other anticholinergic agents. 7. subject has undergone treatment with any investigational drug within 30 days prior to screening procedure. 8. subject has exhibited history of diagnosed gastrointestinal obstructive disease. 9. subjects with co-morbid lower urinary tract symptoms (luts). 10. subjects exhibiting clinically significant bladder outflow obstruction (boo). 11. in the opinion of the study investigator, the patient has exhibited prior to the screening or baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study. 12. subjects who have received prior pelvic radiation. 13. subjects with history of severe hepatic impairment. 14. subjects with history of congenital or acquired qt prolongation.

Keywords: urination disorder overactive bladder prostate cancer radiation vesicare
effectiveness and safety of epivir/ziagen/zerit (3tc/abc/d4t) versus epivir/ziagen/sustiva (3tc/abc/efv) versus epivir/ziagen/agenerase/norvir (3tc/abc/apv/rtv) in hiv patients who have never received treatment

Conditions: HIV Infections

Summary: the purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-hiv treatment: 1) lamivudine (3tc)/abacavir (abc)/stavudine (d4t); 2) 3tc/abc/efavirenz (efv); or 3) 3tc/abc/amprenavir (apv)/ritonavir (rtv).

patients are randomized to initiate antiretroviral therapy in 1 of 3 treatment groups. within each group they are stratified based on hiv-1 plasma rna levels. group 1: patients receive 3tc/abc/d4t; group 2: patients receive 3tc/abc/efv; and group 3: patients receive 3tc/abc/apv/rtv. treatment continues for 96 weeks. blood samples are collected to measure plasma hiv rna and cd4 counts and patients are assessed regularly. in the event of incomplete viral suppression or virologic failure, patients will be switched to secondary therapy.

Eligibility criteria:
inclusion criteria patients may be eligible for this trial if they: * are hiv-positive. * are at least 18 years old. * have a viral load of at least 5,000 copies/ml. * have a cd4 count of at least 50 cells/mm3. * agree to practice effective methods of birth control while on the study, if a woman. patients are not eligible for this trial if they: are pregnant or breast-feeding. have ever taken anti-hiv drugs. (less than 2 weeks of prior anti-hiv treatment is allowed.) have a history of aids-defining opportunistic illness (except for kaposi's sarcoma involving skin) within 45 days of the screening visit. treatment for the illness must have been completed at least 30 days prior to screening. are enrolled in another study where the medication may interfere with the control of viral load in this study. have a serious medical condition such as diabetes or heart problems that would make it unsafe to be on this study. have a history of a severe nerve disease of the type that may cause muscle weakness. have had pancreatitis (inflamed pancreas) or hepatitis within 6 months of starting the study. have had radiation treatment or chemotherapy within 4 weeks prior to study entry, or think those treatments may be needed during the study period. local treatment for kaposi's sarcoma is allowed. have used certain medications, including vaccines, that interfere with the immune system within 4 weeks prior to study entry. have taken an hiv vaccine within 3 months prior to entry. are taking st. john's wort. have a history of being allergic to any of the study drugs.

Keywords: hiv-1 drug therapy, combination stavudine hiv protease inhibitors ritonavir lamivudine vx 478 reverse transcriptase inhibitors anti-hiv agents abacavir efavirenz